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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,3-diyl bis(4-aminobenzoate)
EC Number:
260-847-9
EC Name:
Propane-1,3-diyl bis(4-aminobenzoate)
Cas Number:
57609-64-0
Molecular formula:
C17H18N2O4
IUPAC Name:
3-(4-aminobenzoyloxy)propyl 4-aminobenzoate

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #1 negative control
Value:
0
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #2 negative control
Value:
-0.5
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #3 negative control
Value:
0.98
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean negative control
Value:
0.35
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #4 positive control
Value:
344.23
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #5 positive control
Value:
99.8
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #6 positive control
Value:
157.25
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean positive control
Value:
243.66
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #7 test item
Value:
3.26
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #8 test item
Value:
-0.24
Irritation parameter:
in vitro irritation score
Run / experiment:
Cornea #9 test item
Value:
0.94
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean test item
Value:
1.32

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the evaluation criteria the test item PU-2017-775 is classified into UN GHS No Category.
Executive summary:

The eye irritancy potential of PU-2017-775 was investigated in the bovine corneal opacity and permeability assay.

The test item was suspended with physiological saline 0.9% NaCl (see‎10.3) to give a 20% concentration.

No changes were observed in any of the 3 corneas treated with PU-2017-775.

The following meanin vitroirritation score was calculated:

1.31

Therefore the test item was classified into: UN GHS No Category.

Thein vitroirritation score obtained with the positive control did not fall within the two standard deviations of the current historical mean, however this assay is considered to be valid, because two of three values showed adequate values and the outlier of the positive control showed a higher, a “more positive” result as expected. Wherefore it is assumed that the test resulted altogether in valid results.

The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.